About Karuna Therapeutics
Karuna Therapeutics – A Bristol Myers Squibb Company, a cutting-edge neuroscience company, was in the midst of preparing for a critical U.S. product launch when it encountered the complex regulatory requirements of DSCSA compliance. Two Labs had already been selected as Karuna’s compliance partner when Paul Ellison, Sr. Director, Commercial Supply Chain, joined the company and took over the serialization process. With a small team and limited DSCSA experience, Karuna relied on Two Labs to provide the structure, expertise, and support necessary to meet its compliance needs. From that point forward, Two Labs worked closely with Paul and his team, ensuring that Karuna stayed on track with established timelines and was prepared for launch.
Initial Compliance Challenges
When Karuna began the DSCSA compliance process, the team faced several unique hurdles:
- Resource Gaps and Limited Compliance Experience: As a growing company, Karuna lacked dedicated compliance resources and DSCSA-specific expertise. The complexities of serialization and regulatory requirements were new, and the team needed specialized guidance to build a compliant framework.
- Data Visibility Issues: During testing, Karuna experienced significant visibility gaps in its transactional data when exchanging information with its contract manufacturing organizations (CMOs). Without an experienced partner, Karuna’s team would have struggled to identify and address these data issues effectively.
- Serialization Vendor Instability: Frequent turnover within Karuna’s chosen serialization vendor led to multiple project manager changes, creating delays and continuity challenges. Each transition required new alignment on priorities, stretching Karuna’s timelines and testing its resources.
These challenges required Karuna to collaborate closely with a partner who could quickly identify solutions and navigate the intricacies of DSCSA compliance.
Two Labs’ Approach: Strategic, Supportive, and Solution-Oriented
From the start, Two Labs provided Karuna with a structured roadmap, clear guidance, and responsive support to meet DSCSA requirements. Here’s how the Two Labs team addressed Karuna’s specific needs:
- Creating a Roadmap for Compliance: With limited internal resources and DSCSA experience, Karuna’s team required a structured plan to meet regulatory requirements within tight timelines. To address this, an actionable roadmap was established, prioritizing key tasks and setting clear milestones. This allowed the Karuna team to follow a manageable step-by-step process, building toward launch readiness with clarity and focus.
- Navigating Data and Technical Issues: When Karuna encountered visibility issues in its data exchange with the contract manufacturing organizations (CMOs), the team faced a challenge: identifying the sources of these data gaps and coordinating the necessary adjustments. By systematically reviewing data exchanges and identifying root causes, Two Labs helped Karuna troubleshoot these issues directly with the CMOs, keeping the project on track and preventing delays.
Managing Vendor Transitions and Project Continuity: Throughout the project, frequent turnover in Karuna’s chosen serialization vendor created ongoing disruptions. Each new project manager needed onboarding, which stretched timelines and continuity. Coordinating with new project managers to stabilize workflows, Two Labs helped keep Karuna’s timelines on track, ensuring that progress could continue despite these transitions.
“We couldn’t have done this alone. Two Labs identified root causes and consistently found solutions, even for complex, unfamiliar issues.”
Outcomes and Benefits of the Partnership
Two Labs’ engagement with Karuna produced several tangible outcomes that were critical to the success of the U.S. product launch. One of the most notable achievements was the accelerated timeline for DSCSA compliance. Despite initial hurdles, Karuna was able to complete serialization readiness well ahead of schedule. This early completion provided the team with additional time to focus on other launch preparations, ensuring that all distribution requirements were met with ample time before launch.
The partnership also had a measurable impact on Karuna’s internal efficiency and ability to manage compliance risk. By taking on key responsibilities, such as SOP development and technical troubleshooting, Two Labs enabled Karuna’s internal team to concentrate on core launch activities without becoming overextended. The comprehensive documentation and rigorous data checks established during this period significantly reduced compliance risk and helped Karuna stay aligned with DSCSA standards.
Finally, Two Labs’ responsiveness throughout the project allowed Karuna to achieve these outcomes cost-effectively. Rather than requiring additional internal resources, Karuna relied on Two Labs for timely answers, quick feedback, and solutions that kept the project on course. As Paul reflected, “Two Labs was there to answer questions, provide quick feedback, and keep us moving forward,” a benefit that underscored the value of having a dedicated support team at each critical stage. Together, these factors contributed to a streamlined, efficient compliance process and a successful product launch.
Building a Foundation for Future Success
While Karuna’s acquisition by Bristol Myers Squibb shifted its post-launch compliance strategy, the foundation built with Two Labs provided a robust framework for future regulatory needs.
“If we ever need a partner in compliance again, Two Labs will be our first call.”
Through dedicated support, customized guidance, and deep regulatory expertise, Two Labs enabled Karuna to navigate complex compliance challenges efficiently, laying the groundwork for continued regulatory success.